EMVO - OBP Guide on Divestitures and Acquisitions - Version 2 - Effective Date 06.DEC.2019

Sep 16, 2026

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EMVO OBP Divestitures and Acquisitions guidance defines how marketing authorisation holders should handle divestiture and acquisition scenarios affecting EMVS elements. It sets out three D&A phases tied to marketing authorisation transfer timing, covering contract establishment or updates with EMVO/NMVOs, data upload to the European Hub, production-related topics, alert receipt and processing, and access to product history. The document also explains special merger/acquisition cases where established OBPs and contracts remain unchanged.

LanguageEnglish

CategoryLetters

FormatPDF

Pages19

Reading Time7 min

AccessFree to download

Executive Summary

Introduction

DocuSign Envelope ID: 18151375-DA35-452F-AC7C-CB3E1846AE7F | | | | | | --- | --- | --- | --- | | EMVO: OBP Guide on Divestitures and Acquisitions | | | | | Document Number | Version | Effective Date | Page No | | EMVO_0323 | 2.0 | 06.DEC.2019 | 2 of 20 | Legal Disclaimer This document is provided "AS IS" and for targeted audience’s information only and does not amount to professional advice or recommendations. No warranty of any kind is made or given by the working group that constructed this document (‘the Working Group’) and/or EMVO with respect toit or any use thereof, including, but not limited to, as to its accuracy or completeness. To the fullest extent permitted by applicable law, the Working Group and/or EMVO expressly disclaim all warranties of any kind, whether expressed or implied, including, but not limited to the warranties for hidden or latent defect, of merchantability, fitness for a particular purpose and non-infringement and shall not be liable for any direct or indirect damage, loss or claims, including loss of use, data, profits, benefits, data, business, opportunity, goodwill, clientele, for third party’s claims, or for any other indirect, special, incidental or consequential damages of any kind in connection with or arising out of the use of any information disclosed hereunder. The Working Group and/or EMVO reserve the right to amend this document at any time without prior notice. 1. Executive Summary The purpose of this document is to provide guidance on aspects of the EMVS which might be impacted in Divestiture & Acquisition (D&A) activities ([e.g. data](e.g. data) upload to European Hub, contract of Transferor and Acquirer with EMVO and NMVOs, Quality Assurance Agreement between D&A partners related to data exchange with European Hub) of marketing authorisation holders. This guidance document has been prepared considering D&A scenarios such as 􀁸 Acquisition / divestiture of a part of the business affecting a set of products for a set of markets (i.e. affecting a set of SKUs), 􀁸 Merger of two companies, 􀁸 Acquisition of a company by another company, 􀁸 Scenarios where a new legal entity is created by Transferor prior to divestiture in order to carve out the divested business. In case of the merger of two companies or the acquisition of a company in whole by another company, the merged company or the acquirer respectively might decide – either long-term or for a limited period of time – not to file transfers of marketing authorizations with the authorities and not to touch established contracts with EMVO and NMVO(s) . With regard to EMVO, this means to maintain two separate OBPs and that the affiliation of marketing authorization holders to each of the two OBPs remains unchanged. If these conditions are fulfilled, the activities outlined in the guidance document on hand do not apply. The document outlines the following areas as to be considered in a D&A scenario: 􀁸 Establish/update contracts with EMVO / NMVOs (sec. 3) 􀁸 Data upload (product master data, product pack data) to European Hub (sec. 4) 􀁸 Production-related topics (sec. 5) 􀁸 Receipt and processing of alerts e.g. suspicious pack alerts (sec. 6) 􀁸 Access to product history in European Hub and NMVSs (sec. 7) Throughout the document marketing authorization holders and parallel distributors are treated equally. For both of them, the term ‘Marketing Authorization Holder’ applies. DocuSign Envelope ID: 18151375-DA35-452F-AC7C-CB3E1846AE7F | | | | | | --- | --- | --- | --- | | EMVO: OBP Guide on Divestitures and Acquisitions | | | | | Document Number | Version | Effective Date | Page No | | EMVO_0323 | 2.0 | 06.DEC.2019 | 3 of 20 | 2. Introduction For the purpose of this document, a Divestiture & Acquisition (D&A) activity has been structured into 3 phases as set out in Figure 1 and guided by the following timeline: 1. Prior to submission of Marketing Authorization (MA) transfer to Health Authorit

FAQs

What is the purpose of the EMVO OBP Divestitures and Acquisitions guide?

It provides guidance for EMVS aspects impacted by divestiture and acquisition activities affecting marketing authorisation holders, including contractual, data, production, alerts, and history access considerations.

How many phases does the D&A activity cover in this document?

The D&A activity is structured into three phases based on the marketing authorisation transfer timeline: prior to submission, between submission and implementation date, and after implementation date.

What key considerations apply during Phase 2?

During packaging implementation, the Transferor OBP must continue uploading data and receiving alerts; NTINs remain unchanged; and product codes assigned to an OBP cannot be changed, leading to a need for a Transitional Service Agreement.

Sep 16, 2026

Upload by Eliana